Adverse Drug Reactions Research Articles

Real-World Application of Evolocumab Among Patients with Hyperlipidemia in Korea: A Multicenter Prospective Study.

Elevated low-density lipoprotein cholesterol (LDL-C) is a major residual risk factor among patients with acute coronary syndrome (ACS). In the absence of sufficient real-world evidence, this observational (noninterventional) study investigated the effectiveness and safety of evolocumab in patients with hyperlipidemia treated with evolocumab for ACS in a real-world clinical setting in Korea. Between January 2022 and February 2023, patients from 10hospitals in Korea who initiated evolocumab within 24weeks of an ACS event were enrolled. Data collected at visit1 (evolocumab initiation) included patients' characteristics, comorbidities, and lipid-lowering therapies. LDL-C reduction from visit1 (week0) to visit2 (week8) was assessed. The primary outcome was the proportion of patients who achieved LDL-C < 1.4mmol/L (55mg/dL) at follow-up; the secondary outcome was the proportion who achieved LDL-C < 1.8mmol/L (70mg/dL) at follow-up. In this study, 89 out of 142 enrolled patients were included in the effectiveness analysis. The mean (SD) age of the included patients was 59.3 (12.3) years, with the majority being male (87.6%). Sixty-one patients received statin-ezetimibe combination therapy (68.5%). The median [Q1, Q3] LDL-C level at the start of the study was 2.5 [2.0, 3.0] mmol/L (98 [77, 115] mg/dL), which decreased to 1.3 [0.7, 1.7] mmol/L (49 [29, 67] mg/dL) after 8weeks of evolocumab treatment, resulting in an mean (SD) 50.9 (28.6) % reduction and 1.4 (1.0) mmol/L (55.1 (37.9) mg/dL) absolute reduction. At follow-up, 55.1% and 78.7% of patients achieved LDL-C goals of < 1.4mmol/L (55mg/dL) and < 1.8mmol/L (70mg/dL), respectively. No adverse or serious adverse drug reactions were reported. Evolocumab treatment was associated with significant LDL-C lowering and favorable safety and guideline-recommended LDL-C goal achievement rates among patients with ACS in the real-world clinical practice setting in South Korea.

Effectiveness and safety of lower dose sulfamethoxazole/trimethoprim for Pneumocystis jirovecii pneumonia prophylaxis in patients with systemic rheumatic diseases receiving moderate-to high-dose glucocorticoids

ObjectivesTo compare the effectiveness and safety of low-dose sulfamethoxazole/trimethoprim (SMX/TMP) for Pneumocystis jirovecii pneumonia (PCP) prophylaxis in patients with systemic rheumatic disease (SRD) who were receiving glucocorticoids. MethodsWe retrospectively analyzed data obtained from Japanese patients with SRD who received glucocorticoids between January 2006 and April 2024. Patients were divided into two groups based on the initial dose of SMX/TMP: low-dose (one tablet twice weekly on non-consecutive days); conventional-dose (one tablet per day). The primary endpoint was the incidence of PCP after 1 year since the initiation of SMX/TMP. Secondary endpoints were discontinuation rates of SMX/TMP therapy and severe adverse drug reactions (ADRs) after 1 year since the initiation of SMX/TMP in both groups, before and after adjusting for patient characteristics. ResultsA total of 186 patients were included in this study: 60 in the low-dose group and 126 in the conventional-dose group. No patients developed PCP within one year after starting SMX/TMP; however, two patients in the low-dose group required escalation of the SMX/TMP dose to the conventional dose due to subclinical PCP. In the adjusted analysis, the low-dose group had a significantly lower discontinuation rate and a lower incidence rate of severe ADRs than the conventional-dose group. ConclusionsLower-dose SMX/TMP therapy was as effective as conventional therapy for PCP prophylaxis and was associated with lower discontinuation rates in patients with SRD receiving glucocorticoids.

Promoting Pharmacovigilance: A Review on Significance and Imperative for Establishing Regional Reporting Centres for Adverse Drug Reactions (Adrs)

Promoting Pharmacovigilance: A Review on Significance and Imperative for Establishing Regional Reporting Centres for Adverse Drug Reactions (Adrs)

A Retrospective Observational Study of Adverse Drug Reactions (ADR) Reported to ADR Monitoring Centre from 2010 to 2020.

Adverse Drug Reactions (ADR) are one of the essential causes of hospital admissions and pose a significant clinical and economic burden on the healthcare system. The Adverse Drug Reaction Monitoring Centre (AMC) in JIPMER functioning under the Pharmacovigilance Programme of India (PvPI) plays a vital role in ensuring medication safety by routinely detecting and monitoring ADRs. Hence, this study aimed to assess the characteristics of ADR reported from 2010 to 2020 in AMC JIPMER and to detect signals, if any. To study the characteristics of Adverse Drug Reactions (ADR) reported to a regional ADR monitoring center from 2010 to 2020 and to detect signals of disproportionate reporting (SDRs) if any from the reported ADRs. A total of 6007 ADR reports with a single suspect drug were included for analysis from 2010 to 2020. The characteristics of these reports, including patient's age and gender, Number and percentage of ADRs, the causality of ADR using WHO UMC (World Health Organization-Uppsala Monitoring Scale), the seriousness of the ADR, and outcome were collected from the ADR reports. MedDRA (Medical Dictionary for Regulatory Activities) Preferred Terms (PT) were used to classify adverse drug reactions. Causality analysis using the Naranjo Algorithm and Preventability using Modified Schumock and Thornton criteria were performed for the ADRs. The number and percentage of severe ADRs were analyzed. The System Organ class of all the ADRs was enumerated. ADRs not mentioned in the US FDA (United States Food and Drug Administration) product label (unlabelled reactions) were documented. Unlabeled reactions with ≥3 ADR reports were included for signal detection by disproportionality analysis. Antineoplastic drugs, followed by antimicrobials, anticonvulsants, Anti snake venom, and NSAID were the most common drugs implicated in ADRs. Skin and subcutaneous tissue disorders were the most common System Organ Class (SOC) involved in the ADRs. Among the 6007 reports, 19.2% were serious ADRs. Most of the ADR reports were of possible causality followed by probable and certain as per WHO UMC and Naranjo causality scales. Only ten ADRs were preventable and one reaction (Tamoxifen-induced neuropathy) was eligible for signal detection. Disproportionality analysis using a 2x2 contingency table showed insignificant signal detection using the Reporting Odds Ratio (ROR) and Proportional Reporting Ratio (PRR). Analysis of ADRs from an ADR Monitoring center functioning in a tertiary care hospital shows antineoplastic drugs to be the most common drugs associated with adverse drug reactions, with rash being the most common adverse effect. The majority of the ADRs were not preventable. No Signals of Disproportionate Reporting (SDR) were detected in our study.

Adverse events associated with carbamazepine: a pharmacovigilance study using the FDA Adverse Event Reporting System

ABSTRACT Introduction Carbamazepine (CBZ) is a commonly used antiseizures medications (ASM), but its adverse drug reactions (ADRs) can impact the successful management of epilepsy. There are currently limited systematic studies on ADRs related to CBZ, necessitating further investigation. Areas covered Using the FDA Adverse Event Reporting System (FAERS) database , we extracted reports where CBZ was the primary suspect, conducting subgroup analyses stratified by sex and age. Four risk signal detection methods ROR, PRR, BCPNN, and EGBM were employed to systematically analyze the ADRs associated with CBZ. Expert opinion In the epilepsy population, ADRs related to CBZ often involve examinations, hereditary disorders, and infections. Subgroup analysis showed differences in ADR signals among male, female, elderly, and young patients. Human Herpesvirus 6 Infection and Dermatitis Exfoliative were consistent CBZ-induced ADRs, unaffected by age or sex. The study also identified previously overlooked ADRs such as bone metabolism abnormalities, ocular toxicity, and ototoxicity. Many ADRs linked to CBZ remain underreported. It is crucial to enhance monitoring and information dissemination about CBZ use in epileptic patients. Adjusting medication regimens for high-risk individuals, potentially incorporating acupuncture, traditional Chinese medicine, or alternative anti-seizure medications, should be considered when necessary.

Revolutionizing Patient Safety: Machine Learning and AI for the Early Detection of Adverse Drug Reactions and Drug-Induced Toxicity

Adverse drug reactions and drug-induced toxicity provide significant issues in drug research, jeopardizing patient safety and driving up healthcare costs. Toxicity has a greater potential impact than infectious diseases since it is less visible. Early diagnosis of these difficulties is critical to determining a drug's safety and viability profile. The combination of machine learning and artificial intelligence has marked a watershed moment in the identification of early adverse drug reactions and toxicity. These computational approaches enable rapid, extensive, and precise prediction of likely adverse drug reactions and toxicity even before practical drug manufacture, preclinical testing, and clinical trials. This paradigm change strives to create more efficient and safe drugs, lowering the likelihood of drug withdrawal. This comprehensive review investigates the critical role of machine learning and artificial intelligence in quickly detecting adverse drug reactions and toxicity, including approaches from data mining to deep learning. It lists essential databases, modelling techniques, and software that may be used to model and predict a wide range of toxicities and adverse drug reactions. This review provides a comprehensive overview, outlining recent developments and projecting future opportunities in machine learning and artificial intelligence-driven rapid identification of adverse drug reactions and drug-induced toxicity. It highlights the capabilities of these technologies and their enormous potential to improve patient safety and revolutionize medication discovery.

Pattern of Adverse Drug Reactions and Performed Monitoring Laboratory-Tests in Patients Receiving Anti Tuberculosis Treatment in an Endemic Region, Zabol

Background: Efficient anti TB treatment considered crucial globally. Anti TB drugs can cause various adverse drug reactions (ADRs). Clinical and laboratory monitoring will decrease rate of these ADRs, improve patient safety as well as drug adherence and treatment outcome. Methods: In this cross-sectional study total of 136 newly diagnosed TB patients were included. All patients received standard anti-TB 4 drug regimen. Predesigned data collection forms were used to gather patient’s lab data as well as clinical symptoms they experienced during treatment course. Monthly follow up visits or phone calls were also performed by investigators and all health issues were recorded. Results: The majority of our patients aged over 70-year-old. About 54% of them were female. We recorded at least one ADR in 80.8% of patients, and hepatic-gastrointestinal (GI) ADRs ranked first (64.7%). Although ADRs were more common in women and patients over 70-year-old, but there was no statistically significant relationship between sex or age and rate of ADRs (P&gt; 0.05). We also observed that recommended baseline laboratory tests for monitoring anti TB treatment was not performed in any of our patients, except complete blood count (CBC) that was performed in 11 cases. This led to diagnoses of anemia and thrombocytopenia in one case. Conclusion: The majority of our patients experienced ADR. Recommended drug monitoring tests that could guarantee safe and effective treatment were not performed routinely in our TB management centres. These facts highlighted the importance of improving surveillance system for TB management based on national standards.

Real-world analysis of safety, tolerability, and adherence to nirmatrelvir-ritonavir (paxlovid) in primary care COVID-19 outpatients.

This retrospective cross-sectional study aims to evaluate the safety, tolerability, and adherence of patients prescribed Nirmatrelvir-ritonavir (Paxlovid) in outpatient settings, focusing on its use in managing category 2 COVID-19 patients across three primary healthcare clinics in Selangor, Malaysia. Data were collected from the Paxlovid pharmacy registry and medical records at Klinik Kesihatan Seksyen 7, Klinik Kesihatan Seksyen 19, and Klinik Kesihatan Kelana Jaya between April 1, 2022, and November 30, 2022. This study analysed data from 415 category 2 COVID-19 patients aged ≥ 18years. The primary and secondary outcomes included the assessment of patient demographics, Paxlovid dosing, current medication, changes in drug regimen, adherence, and adverse drug reactions (ADR). Pharmacists follow-ups were conducted on days 3 and 5 post-medication initiation. The majority (79.5%) of the cohort experienced ADR, predominantly dysgeusia, diarrhoea, body ache, vomiting, and nausea. Despite this, the ADRs were generally well-tolerated, with no severe impacts reported. High adherence was observed, with 96.9% of patients completing the 5-day regimen. The primary reasons for non-adherence included adverse effect intolerability, dosing ambiguity, forgetfulness, concerns about ADR, and perceived health improvement. Notable medications interacting with Paxlovid were simvastatin, amlodipine, and atorvastatin, and 21.7% of 23 concurrent medications were found not to comply with the recommended interventions by the University of Liverpool COVID-19 Drug Interaction database. Paxlovid demonstrates a high level of safety and tolerability in outpatient COVID-19 patients, with optimal adherence observed. This study underscores the vital role of healthcare professionals in managing Paxlovid within primary healthcare and highlights the need for broader research and direct patient involvement to enhance treatment strategies against COVID-19.

Pharmacovigilance monitoring and treatment adherence in patients on antihypertensive drugs at a tertiary care centre.

Hypertension is one of the main factors contributing to the global burden of non-communicable diseases. Previous research has revealed that stress, bad lifestyle choices and a lack of knowledge about the disease are the main causes of hypertension that can be controlled. The key cause behind the prevalence of the condition is the lack of medication adherence by patients. This study aims to evaluate medication adherence in patients with hypertension through the Morisky Medication Adherence Scale (MMAS) and to observe any adverse drug reaction leading to non-adherence of medications. A descriptive, cross-sectional study was conducted on 124 patients who attended the outpatient department of medicine. The descriptive tools were MMAS and causality scales for adverse drug reactions. The mean MMAS score was 5.20±1.29. Amongst the demographic profile, age, sex, comorbidities and duration of disease were significantly associated with decreased mean MMAS scores. Forty-two patients experienced drug reactions and only four patients were adherent to their medications. Our study suggests that patients were poorly adherent to their medications. Effective interventions should be considered to improve adherence in patients. Monitoring for adverse drug reactions can lead to improved patient outcomes, whilst interventions to improve adherence can lead to better blood pressure control and reduced risk of cardiovascular events.

Real-World Effectiveness and Safety of Carotegrast Methyl in Japanese Patients with Moderately Active Ulcerative Colitis

Introduction: Carotegrast methyl (CGM) is an oral, small-molecule α4-integrin antagonist, which became clinically available in Japan in May 2022. CGM is approved for remission induction treatment for moderately active ulcerative colitis (UC) with an inadequate response or intolerance to 5-aminosalicylates. Methods: We performed a single-center, retrospective, observational study of Japanese patients with moderately active UC to assess the real-world effectiveness and safety of CGM as remission induction treatment. Results: Of 14 patients, 71% (10/14) were women, and the median (range) age was 47 (20–68) years. Disease types were proctitis in 7% (1/14), left-sided colitis in 50% (7/14), and total colitis in 43% (6/14). With a median (range) treatment duration of 8 (2–26) weeks, the rate of endoscopic improvement (Mayo endoscopic subscore [MES] of 0 or 1) was 64% (9/14), and the rate of endoscopic remission (MES of 0) was 57% (8/14). After treatment with CGM, the median (range) MES decreased significantly from 3.0 (2–3) to 0.0 (0–3) (p = 0.008), the Mayo score decreased significantly from 7.0 (5–9) to 0.0 (0–9) (p = 0.006), and the clinical activity index decreased significantly from 6.0 (1–11) to 0.0 (0–9) (p = 0.015). Stool and diarrhea frequencies decreased significantly after initiating CGM, and the percentage of patients with bloody stool and abdominal pain tended to decrease. The cumulative relapse-free rate at week 26 among 9 patients who achieved endoscopic improvement with CGM was 77.8% (95% confidence interval, 36.5%–93.9%). No adverse drug reactions, including progressive multifocal leukoencephalopathy, were reported during the study period. Conclusion: This single-center, retrospective, observational study of 14 Japanese patients with UC showed that CGM was safe and effective as a remission induction treatment for moderately active UC with an inadequate response to 5-aminosalicylates in real-world settings.

Predictive machine learning models for anticipating loss to follow-up in tuberculosis patients throughout anti-TB treatment journey

Loss to follow-up (LTFU) in tuberculosis (TB) management increases morbidity and mortality, challenging effective control strategies. This study aims to develop and evaluate machine learning models to predict loss to follow-up in TB patients, improving treatment adherence and outcomes. Retrospective data encompassing tuberculosis patients who underwent treatment or registration at the National Center for Clinical Medical Research on Infectious Diseases from January 2017 to December 2021 were compiled. Employing machine learning techniques, namely SVM, RF, XGBoost, and logistic regression, the study aimed to prognosticate LTFU. A comprehensive cohort of 24,265 tuberculosis patients underwent scrutiny, revealing a LTFU prevalence of 12.51% (n = 3036). Education level, history of hospitalization, alcohol consumption, outpatient admission, and prior tuberculosis history emerged as precursors for pre-treatment LTFU. Employment status, outpatient admission, presence of chronic hepatitis/cirrhosis, drug adverse reactions, alternative contact availability, and health insurance coverage exerted substantial influence on treatment-phase LTFU. XGBoost consistently surpassed alternative models, boasting superior discriminative ability with an average AUC of 0.921 for pre-treatment LTFU and 0.825 for in-treatment LTFU. Our study demonstrates that the XGBoost model provides superior predictive performance in identifying LTFU risk among tuberculosis patients. The identification of key risk factors highlights the importance of targeted interventions, which could lead to significant improvements in treatment adherence and patient outcomes.

Medication Adherence and Practices in Pediatric Patients

Background: Improper medication practices and non-adherence are the biggest challenges faced by pediatricians in outpatient practice. Hence this study was aimed at determining the medication practices and factors affecting adherence. Methods: A cross sectional descriptive study was conducted at a tertiary care hospital in Southern India over a period of 3 months (January to March 2023), to study medication adherence and parental medication practices in pediatric patients. A pre structured questionnaire was administered to parents of 320 children. Results: Majority of the parents (55%) had children aged 1-5 years of age. It was noted that most of the families (89%) were above poverty line (APL). About 34% parents were educated till graduate level and 17% were educated beyond post graduate level. Frequency of medication adherence in our study was found to be 78%. It was noted that parents with education of graduate level and above, those belonging to APL families and the ones with no fear of adverse drug reactions showed higher medication adherence as compared to other parents and this association was found to be statistically significant (p &lt;0.001). Majority of the parents (80%) reported that their children preferred liquid formulations, of which 57% preferred fruit flavoured ones. Around 51% parents preferred twice daily dosing of medications. While 47% parents used previous prescriptions, 39% bought over the counter medicines, especially paracetamol. Conclusion: Knowledge about medication practices and factors affecting adherence is important in order to provide quality health care. Actively involving children and parents while prescribing medications with health education goes a long way in improving adherence.

Therapeutic drug monitoring and safety of voriconazole in patients with liver dysfunction.

This study aims to describe the distribution characteristics of voriconazole (VRC) plasma trough concentrations (Ctrough) in patients with liver dysfunction, identify factors influencing VRC Ctrough, and provide recommendations for the use of VRC in this population. We retrospectively collected medical records of hospitalized patients with liver dysfunction who used VRC and underwent therapeutic drug monitoring (TDM) at the First Hospital of Changsha. The severity of liver dysfunction was assessed by the Child-Pugh (CP) score. Multiple linear regression was employed to explore factors affecting VRC Ctrough in these patients. A total of 147 Ctrough from 102 patients with liver dysfunction were analyzed. Patients were categorized into a control group (n = 40), CP-A (n = 39), CP-B (n = 11), and CP-C group (n = 12). The initial probability of target attainment of Ctrough was 70.6%, with 6.9% of patients obtaining subtherapeutic Ctrough and 22.5% obtaining supertherapeutic Ctrough. The initial Ctrough in CP-A and B were 5.05 (0.64-9.57) mg/L and 5.37 (0.26-10.01) mg/L, respectively, significantly higher than the control group (P = 0.021 and P = 0.010). The proportion of VRC Ctrough of >5.5 mg/L in CP-A and B was 33.3% and 45.5%, respectively. Multiple linear regression analysis revealed that factors such as age ≥70 years, CP class, C-reactive protein (CRP), and direct bilirubin were significantly related to the initial VRC Ctrough. Among all measurements, patients with severe inflammation (CRP >100 mg/L), aged ≥70 years, and albumin levels of <30 or <25 g/L had significantly higher VRC Ctrough. The treatment success rate of VRC was 69.6% (71 of 102), and the rate of VRC-related adverse drug reactions was 29.4% (30 of 102). The recommended half-maintenance dose may lead to elevated VRC Ctrough in patients with CP-A and CP-B. TDM is essential for patients with advanced age, severe infections, or hypoalbuminemia to prevent excessive VRC trough levels.

Adverse drug reactions in older people following hospitalisation: a qualitative exploration of general practitioners' perspectives.

Older people have greater comorbidity and medication burden. Adverse drug reactions occur in up to 30% of older people within one month of hospital discharge. General practitioners are key stakeholders in transitions of care from hospital to the community. The study aimed to explore general practitioner perspectives of adverse drug reactions in older people after hospitalisation, investigating the medication-related issues encountered and possible approaches to reduce the risk. An invitation to participate in the study was sent to general practitioners in Southern Tasmania, Australia. A semi-structured interview occurred in person at their practice or online. The questions covered experiences with managing medication in older people after hospital discharge, challenges and risks involving adverse drug reactions and suggestions to prevent adverse drug reactions. The interviews were transcribed and analysed through thematic analysis. Twelve general practitioners were interviewed, revealing four themes describing challenges, including (i) complex patients and acceptance of risk, (ii) patient confusion and decline in hospital, (iii) time taken to manage older patients and (iv) communication challenges. Three themes describing recommendations were identified, including (i) clear communication on discharge, (ii) patient involvement and (iii) roles for pharmacists. Prevention of adverse drug reactions after hospital discharge may require clear and timely communication to general practitioners, patients and families to be educated and empowered to help manage their own health and risk, and pharmacists to support both patients and general practitioners in managing the risks.

The role of trimethoprim/sulfamethoxazole in preventing opportunistic infections in systemic lupus erythematosus patients receiving low-level immunosuppressive treatment: an open-label, randomized, controlled trial

Objective: Systemic lupus erythematosus (SLE) patients receiving immunosuppressive therapy are at risk for opportunistic infections (OIs), particularly Pneumocystis pneumonia (PCP). This study aimed to evaluate the effectiveness of trimethoprim/sulfamethoxazole (TMP/SMX) as primary prophylaxis against OIs and its adverse effects in SLE patients receiving low-level immunosuppressive treatment in a real-world setting. Methods: This open-label randomized controlled trial enrolled SLE patients receiving low-level immunosuppressive treatment at Ramathibodi Hospital between May 2021 and December 2022. Patient demographics and relevant clinical data were collected. Participants were randomized 1:1 to receive TMP/SMX or no prophylaxis, with dose adjustments according to renal function. The incidences of TMP/SMX-sensitive OIs and adverse events were monitored for 12 months post-enrollment. Results: The trial was terminated early due to a high rate of adverse drug reactions (ADRs) associated with TMP/SMX. In total, 138 SLE patients receiving low-level immunosuppressive treatment were enrolled. Most patients (98.4%) were in disease remission. No TMP/SMX-sensitive OIs were observed in either group during the 12-month follow-up period. Among individuals receiving TMP/SMX, 10/70 (14.3%) developed ADRs. Of these 10 patients, eight experienced grade 1 ADRs, and two had grade 3 ADRs; all declined to resume prophylaxis. There were no deaths in the study. Conclusions: During the 12-month follow-up period, no TMP/SMX-sensitive OIs occurred in SLE patients receiving low-level immunosuppressive therapy, suggesting that primary prophylaxis with TMP/SMX may not significantly benefit this population. The high rate of ADRs observed underscores the need for clinicians to carefully consider the risks and benefits of TMP/SMX prophylaxis in these patients.

Pharmacogenetic DPYD allele variant frequencies: A comprehensive analysis across an ancestrally diverse Iranian population.

Cancer treatment has improved over the past decades, but many cancer patients still experience adverse drug reactions (ADRs). Pharmacogenomics (PGx), known as personalized treatment, is a pillar of precision medicine that aims to optimize the efficacy and safety of medications by studying the germline variations. Germline variations in the DPYD lead to significant ADRs. The present cross-sectional study aims to evaluate the allele frequency of the DPYD gene variations in the Iranian population to provide insights into personalized treatment decisions in the Iranian population. The allele frequency of 51 pharmacogenetic variations in the clinically relevant DPYD was assessed in a representative sample set of 1142 unrelated Iranian individuals and subpopulations of different ethnic groups who were genotyped using the Infinium Global Screening Array-24 BeadChip. The genotyping assay revealed eight pharmacogenetic variants including DPYD rs1801265 (c.85T > C; DPYD*9A), rs2297595 (c.496A > G), rs1801158 (c.1601G > A; DPYD*4), rs1801159 (c.1627A > G; DPYD*5), rs1801160 (c.2194G > A; DPYD*6), rs17376848 (c.1896T > C), rs56038477 (c.1236G > A; HapB3), and rs75017182 (c.1129-5923C > G; HapB3) with minor allele frequency (MAF) ≥ 1%. The results of the study reveal significant genetic variations among Iranian population that could significantly influence clinical decision-making. These variants, with their potential to explain the substantial variability in drug response phenotypes among different populations, shed light on a crucial aspect of pharmacogenomics. These findings not only provide valuable insights but also inspire the design and implementation of future pharmacogenomic clinical trials, motivating further research in this crucial area.

Substituting with alternativeiodinated contrast medium to prevent recurrent adverse drug reactions associated with its use: a meta-analysis.

To systematically review and meta-analyze the recurrent rate of iodinated contrast medium (ICM)-associated adverse drug reactions (ADRs) and the preventive effect of using alternative ICM lacking a common carbamoyl side chain. A systematic literature search was conducted in the MEDLINE and EMBASE databases to identify studies that investigated the recurrence rate of ICM-associated ADRs or hypersensitivity reactions (HSRs). Studies that included patients who subsequently underwent contrast-enhanced computed tomography scans after their index reactions were included, while studies with overlapping cohorts were excluded. The first search was conducted on November 10, 2023. The pooled recurrence rate of ICM-associated ADR was determined using the DerSimonian-Laird random-effects model. Subgroup analyses were also conducted based on the substitution of ICM, with particular consideration given to the N-(2,3-dihydroxypropyl) carbamoyl side chain. A total of ten original articles were included in the analysis, collectively spanning from June 2001 to March 2021. The pooled recurrence rate of ICM-associated ADR was not significantly different from that of ICM-associated HSR (16.6% [95% CI, 7.8-31.9%] vs. 15.5% [95% CI, 10.8-21.8%], p = 0.87). In the subgroup analyses, the pooled odds ratio for ICM-associated recurrent ADR when using a different ICM compared with using the same ICM was 0.31 (95% CI, 0.21-0.45), which means a 69% reduction. Moreover, the pooled odds ratio for ICM-associated recurrent ADR when substituting ICMs with different side chains compared with substituting with common side chains was 0.65 (95% CI, 0.52-0.82), which means an additional 35% reduction. Substituting with an alternative ICM led to a 69% reduction in recurrent ADRs, with an additional 35% reduction observed when using ICM lacking a common carbamoyl side chain. Question No standardized guidelines exist for replacing previously used iodinated contrast medium (ICM) to prevent recurrent adverse reactions. Findings Using alternative contrast medium with a different carbamoyl side chain prevents adverse drug reactions effectively. Clinical relevance This study advocates using alternative ICM without a common carbamoyl side chain to prevent recurrent adverse drug reactions in patients with a history of such events.

Adverse reaction of specific acute kidney injury caused by atorvastatin: an actual study based on the database of the US FDA adverse event reporting system

ABSTRACT Introduction Atorvastatin, one of the most widely used drugs, has attracted controversy regarding its potential adverse reactions to acute kidney injury(AKI). This study aims to provide evidence in support of the safe use of atorvastatin. Areas Covered Using the FDA Adverse Event Reporting System (FAERS) database (Q1 2004 to Q1 2024), we extracted reports where atorvastatin was the primary suspect and categorized them into five populations: the general population, acute myocardial infarction (AMI), ischemic stroke (IS), type 2 diabetes mellitus (T2DM), and hyperlipidemia (HLD). We performed subgroup analyses by gender and age strata within these populations, assessing positive signals through disproportionality analysis using four criteria: Ratio of Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EGBM). The statistical analysis evaluated differences between adverse drug reaction (ADR) occurrence and nonoccurrence, as well as between high and low induction time groups. Expert Opinion In the general population, evidence for a positive signal of AKI was insufficient. However, the sub-group analysis revealed a risk in males, with older individuals more often affected in both AMI and IS populations. In T2DM, positive signals were evident in younger age groups. For the HLD population, evidence of a positive AKI signal was insufficient across gender and age strata. Overall, atorvastatin is generally safe, but clinical vigilance for AKI is warranted in T2DM, AMI, and IS populations, particularly in older adults (65+ years).

A case report of adolescent lactation due to the drug blonanserin

BackgroundSecond-generation antipsychotic drugs are increasingly used to treat depressive disorders with psychotic symptoms. In addition to effectively managing psychotic symptoms, second-generation antipsychotics can also result in adverse drug reactions in patients, which should not be underestimated.Case presentationWe report the case of 14 years old unmarried female patient with depression. At first, she started with moping and gradually developed into self-injury and whispering. After antidepressant treatment combined with the second-generation antipsychotic drug blonanserin, the patient’s psychotic and depressive symptoms improved significantly, while the patient developed lactation, which stopped after the medication was changed.ConclusionsAlthough Blonanserin’s clinical trials have reported rare adverse reactions like elevated prolactin levels and even lactation, caution is still needed in clinical application of the drug. This case is expected to improve psychiatrists’ choice of antidepressant therapy in combination with antipsychotic drugs.

Investigating the Impact of the Number of Medication Use on Depression Among Hypertensive Patients: Results from the National Health and Nutrition Examination Survey Database.

Background and Objective: Hypertension is a prevalent chronic condition often treated with multiple medications, leading to polypharmacy, which can heighten the risk of adverse drug reactions and contribute to psychological issues like depression. This study aimed to investigate the relationship between polypharmacy and depressive symptoms in hypertensive patients using data from the National Health and Nutrition Examination Survey (NHANES) from 2017 to 2020. Materials and Methods: This study utilized data from the National Health and Nutrition Examination Survey (NHANES) collected between 2017 and March 2020. Results: Among 2543 hypertensive participants, 12.3% met the criteria for depression. The findings revealed that patients using 11 or more medications were ten times more likely to experience depressive symptoms compared to those taking 1 to 2 medications (OR = 10.06, p < 0.001). Additionally, younger age (18 to 45 years), female gender, and lower educational attainment were significantly associated with higher rates of depressive symptoms. Specifically, females were 1.47 times more likely to experience depression compared to males (p = 0.032). Conclusions: This research highlights the substantial impact of medication burden on mental health among hypertensive patients, emphasizing the need for tailored clinical interventions for this vulnerable population.